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NCT07355309
High-Dairy Food Patterns and Gut-Brain Axis
NA trial testing High-dairy food pattern in Brain Insulin Sensitivity in 40 participants. Not yet recruiting.
1 April 2027
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 22 December 2025 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 April 2027 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- High-dairy food pattern
- Low-dairy food pattern
Conditions studied
- Brain Insulin Sensitivity — all drugs for Brain Insulin Sensitivity →
- Brain Vascular Function — all drugs for Brain Vascular Function →
- Cerebral Blood Flow — all drugs for Cerebral Blood Flow →
- Cognitive Performance — all drugs for Cognitive Performance →
Sponsor
Maastricht University Medical Center
Who can join
Adults 40 to 75, any sex, with Brain Insulin Sensitivity or Brain Vascular Function. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Disturbances in brain insulin sensitivity are associated not only with obesity and type 2 diabetes, but also with brain aging and cognitive decline. Longitudinal studies suggest that dietary patterns, particularly those high in dairy intake, may impact brain function via the gut-brain axis. Indeed, dairy foods are known to modulate gut microbiota and may, through this pathway, not only improve brain insulin sensitivity and cognitive performance, but also mental health and appetite regulation. However, underlying mechanisms remain largely unexplored. The primary objective of this study is to evaluate, in older adults with overweight or obesity, the effects of a high-dairy food pattern (4-5 daily servings of (butter)milk, cheese, yogurt, or cottage cheese) compared to a low-dairy food pattern (≤1 serving daily) on (regional) brain vascular function and insulin sensitivity. These outcomes will be quantified using the non-invasive MRI perfusion technique Arterial Spin Labeling (ASL), which assesses cerebral blood flow (CBF) in response to intranasal insulin, a validated physiological marker of brain insulin sensitivity. Secondary objectives include changes in cognitive performance (via the CANTAB neuropsychological test battery), gut microbiota composition (via shotgun metagenomic analysis of fecal samples), and appetite-related brain reward activity (via BOLD-fMRI with food cues). Exploratory analyses include conventional cardiometabolic risk markers (blood pressure, lipid and glucose metabolism), and perceivable (consumer) benefits.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07355309
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Brain Insulin Sensitivity
Currently open trials in the same condition.
- NCT07057245 — Effects of Protein Supplementation on Brain Function · NA · recruiting
Other Maastricht University Medical Center trials
Trials by the same sponsor.
- NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
- NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
- NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
- NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
- NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07355309 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 21 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07355309.
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